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| Sponsored by: |
National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00024635 |
Purpose
The purpose of this protocol is to allow for the careful screening of patients and healthy volunteers for participation in research protocols in the Mood and Anxiety Disorders Program (MAP) at the National Institute of Mental Health (NIMH) and for the collection of natural history data. Subjects in this protocol will undergo an evaluation which may include: a psychiatric interview; a diagnostic interview; rating scales; a medical history; a physical exam; brain magnetic resonance imaging (MRI); electroencephalography (EEG); magnetoencephalography (MEG); blood and urine laboratory evaluation; and a request for medical records. The data collected may also be linked with data from other mood and anxiety disorder protocols (e.g., brain imaging, DNA, psychophysiology tests, treatment studies, etc) for the purposes of better understanding the diagnosis, pathophysiology, and treatment response of patients with mood disorders. Parents of minors will be interviewed. Upon conclusion of the screening process, subjects will either be offered participation in a research protocol and will sign the appropriate informed consent, or will be considered not appropriate for participation in research and will be referred back into the community. The current protocol thus serves as an entry point for individuals with mood or anxiety disorders or healthy volunteers to enter NIMH IRB approved MAP protocols....
| Condition |
|---|
|
Mood Disorder Anxiety Disorder |
| Study Type: | Observational |
| Official Title: | The Evaluation of Patients With Mood and Anxiety Disorders and Healthy Volunteers |
| Estimated Enrollment: | 16000 |
| Study Start Date: | September 2001 |
The purpose of this protocol is to allow for the careful screening of patients and healthy volunteers for participation in research protocols in the Mood and Anxiety Disorders Program (MAP) at the National Institute of Mental Health (NIMH) and for the collection of natural history data. Subjects in this protocol will undergo an evaluation which may include: a psychiatric interview; a diagnostic interview; rating scales; a medical history; a physical exam; brain magnetic resonance imaging (MRI); electroencephalography (EEG); magnetoencephalography (MEG); blood and urine laboratory evaluation; and a request for medical records. The data collected may also be linked with data from other mood and anxiety disorder protocols (e.g., brain imaging, DNA, psychophysiology tests, treatment studies, etc) for the purposes of better understanding the diagnosis, pathophysiology, and treatment response of patients with mood disorders. Parents of minors will be interviewed. Upon conclusion of the screening process, subjects will either be offered participation in a research protocol and will sign the appropriate informed consent, or will be considered not appropriate for participation in research and will be referred back into the community. The current protocol thus serves as an entry point for individuals with mood or anxiety disorders or healthy volunteers to enter NIMH IRB approved MAP protocols.
Eligibility| Ages Eligible for Study: | 3 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Subjects must be competent to comprehend the purpose of the screening process and to provide written informed consent and be willing to participate in NIMH IRB approved research protocols. Minors will be asked to assent and their parents will sign the consent form.
Subjects will undergo an evaluation which may include a psychiatric interview, medical (including Tanner staging for minors), neurological, and laboratory examinations (as appropriate such as EKG, EEG, renal and liver function tests, serum electrolytes, urinalysis, HIV, hepatitis A, B, and C, blood levels of psychotropic drugs, pregnancy testing, and urine drug screen for the presence of psychoactive drugs and drugs of abuse).
EXCLUSION CRITERIA:
Subjects should have no general medical illness that is primary (i.e., appears to be causing the mood disorder or anxiety disorder).
Current alcohol or substance use or dependence (excluding nicotine) of sufficient magnitude to require independent, concurrent treatment intervention (e.g., antabuse or opiate treatment, but not including self-help groups).
Whether the minor lives with both parents or one parent, the parent(s) he/she lives with must have legal custody. If a parent has shared custody, both parents must consent to participate in this protocol.
Contacts and Locations| Contact: Brenda Y. Gray | (877) 646-3644 | moodresearch@mail.nih.gov |
| Contact: Libby Jolkovsky | (877) 646-3644 | libby_jolkovsky@nih.gov |
| United States, District of Columbia | |
| Childrens National Medical Center | Recruiting |
| Washington, District of Columbia, United States | |
| United States, Maryland | |
| Suburban Hospital | Recruiting |
| Bethesda, Maryland, United States, 20814 | |
| United States, New Jersey | |
| Rutgers University | Recruiting |
| New Brunswick, New Jersey, United States, 08901 | |
More Information
| Study ID Numbers: | 010254, 01-M-0254 |
| Study First Received: | September 23, 2001 |
| Last Updated: | September 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00024635 |
| Health Authority: | United States: Federal Government |
|
Screening Psychiatric History Medical History Diagnostic Evaluation Physical Examination Mood Anxiety Diagnostic Testing |
Anxiety HV Healthy Volunteer Normal Control Mood Disorder PTSD Post-Traumatic Stress Disorder |
|
Anxiety Disorders Mental Disorders Mood Disorders Stress Disorders, Post-Traumatic |
Stress Healthy Stress Disorders, Traumatic |
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Pathologic Processes Disease |
